Boehringer Ingelheim Presents Efficacy Data for Tiotropium in Symptomatic Asthma Patients in Relation to Allergic Status

San Antonio, Texas, Feb. 23, 2013 – Boehringer Ingelheim presented today a new subset of data from the Phase III UniTinA-asthma^TM program at the 2013 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in San Antonio, Texas. In prespecified subgroups from two paired clinical trials, tiotropium delivered once daily via the Respimat^® inhaler improved lung function and asthma control, as defined by a decrease in asthma exacerbations or worsening of asthma, in patients with poorly controlled asthma, irrespective of their allergic status. Patients included in the study remained symptomatic despite current treatment with at least high dose inhaled corticosteroids (ICS) and long-acting beta agonists (LABA).

“Patients with asthma may respond differently to treatment based on their allergic status, therefore it is important to investigate new therapies in both allergic and non-allergic patients,” said Mark Vandewalker, MD, director, Clinical Research of the Ozarks, Columbia, Missouri. “The results of these trials show that tiotropium provides additional bronchodilation and reduces exacerbation rates in asthmatics who are uncontrolled on current therapy with at least ICS/LABA regardless of their allergic status, thus demonstrating its potential benefit for patients who need additional asthma control.”

The two PrimoTinA-asthma^TM studies were replicate double-blind parallel-group trials including asthma patients with post-bronchodilator FEV₁ less than 80 percent predicted and asthma control questionnaire score of greater than or equal to 1.5, while on at least high dose ICS/LABA. A total of 912 patients were randomized to receive tiotropium 5 μg or placebo in addition to usual care for 48 weeks. In addition to ICS/LABA, patients in the trials were permitted to receive additional background therapy, including antihistamines, anti-allergic agents, nasal steroids and omalizumab. The subgroup of patients with potentially allergic asthma was identified using three criteria: total serum immunoglobulin E (IgE), blood eosinophilia, or clinician judgment (CJ). Allergic status was positive if serum IgE was greater than 430 μg/L, blood eosinophilia was greater than 0.6 x 10⁹/L, or CJ was “yes.”

Peak FEV₁ improved with tiotropium in Trial 1 irrespective of allergic status for IgE (P=0.86) and eosinophilia (P=0.46) and in Trial 2 for IgE (P=0.98), eosinophilia (P=0.18) and CJ (P=0.29). Predose (trough) FEV₁ improved with tiotropium compared with placebo, irrespective of allergic status, across all criteria in Trial 1 (IgE, P=0.85; eosinophilia, P=0.83; and CJ, P=0.15) and Trial 2 (IgE, P=0.58; eosinophilia, P=0.38; and CJ, P=0.85). Pooled prespecified data analyses revealed that time to first severe asthma exacerbation and time to first asthma worsening were both increased with tiotropium compared with placebo, regardless of allergic status, based on the three criteria. In the overall study population, patients who received tiotropium had an improved time to first severe asthma exacerbation (risk reduction 21 percent; hazard ratio [HR] 0.79; P=0.03) and time to first asthma worsening (risk reduction 31 percent; HR 0.69; P<0.001), compared with patients receiving placebo.

Adverse events (AEs) were balanced between the allergic and non-allergic subgroups. The most frequently reported treatment-emergent AEs in both Phase III studies included asthma, peak expiratory flow (PEF) rate decrease and nasopharyngitis.

“Through the UniTinA-Asthma^TM program, our goal is to evaluate tiotropium in a wide range of asthma patients to determine where there may be a benefit,” said Tunde Otulana, MD, vice president, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. “We are encouraged by these findings, as they provide us with more information on tiotropium’s potential across new subsets of asthma patients.”

About UniTinA-Asthma^TM
The PrimoTinA-asthma^™ studies are a part of the comprehensive Phase III trial program UniTinA-asthma^™ which includes a number of clinical trials in adults, adolescents and pediatric patients across different asthma severities who remain symptomatic/uncontrolled on current treatment with inhaled corticosteroids. The program includes over 4,000 patients in more than 150 sites globally.

About Asthma
Asthma is a chronic disease characterised by airway inflammation and bronchoconstriction. When a person with asthma comes into contact with an asthma trigger (e.g. infections, pollen, smoke), their airways can become inflamed, swollen and constricted and excess mucus is produced. These reactions can cause the airways to become narrower and irritated, making it difficult to breathe. People suffering from asthma experience recurrent episodes of wheezing, breathlessness, chest tightness and coughing. 

As of May 2011, an estimated 235 million people worldwide suffer from asthma. Estimates have shown that the number of people with asthma could grow by an additional 100 million people worldwide by 2025.

By avoiding asthma triggers, one can help to reduce the severity of asthma. Although asthma cannot be cured, appropriate management can control the disease in many patients. However, many patients still suffer from uncontrolled asthma despite the available treatment options. They can continue to have symptoms and lifestyle restrictions and might even require emergency care.

Leading respiratory forward
Through research, treatments and patient-centric support services, the Boehringer Ingelheim (BI) lung health portfolio is designed to help address the challenges people living with a lung disease face every day. Leveraging the company’s cutting edge science and leadership in chronic obstructive pulmonary disease (COPD), BI is researching new treatment approaches where needs persist. It is the company’s goal to make a difference in the lives of patients with COPD, asthma, lung cancer, idiopathic pulmonary fibrosis and other respiratory diseases.

About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. Subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 44,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to act in a socially responsible manner. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavors.

In 2011, Boehringer Ingelheim achieved net sales of about $17.1 billion (13.2 billion euro). R&D expenditure in the business area Prescription Medicines corresponds to 23.5 percent of its net sales.

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